Pain After Strabismus Surgery

ConditionStrabismus
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-12
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

About this trial

At Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's), the current practice is to prescribe children with oral Tylenol as needed every 4-6 hours post strabismus surgery. Prescribing Tylenol "as needed" leaves more room for error for parents to be under-dosing their children, which can lead to avoidable pain. This study aims to figure out if children ages 4-12 years old will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (eye muscle surgery) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery. To date, there have been no studies comparing patient outcomes between those taking Tylenol regimen and those receiving Tylenol as needed after pediatric surgery.

Eligibility criteria

Qualifiers

Children between 4-12 years old

Children receiving single muscle, bilateral horizontal strabismus surgery (that is, children who are having only one horizontal eye muscle in each eye operated on) at Lurie Children's hospital in Chicago, IL

ASA classification 1 or 2. Note: ASA is a physical status classification system (scale of 1-6) created by the American Society of Anesthesiologists to describe patients prior to surgery. ASA 1 or 2 means the patient is either healthy or has mild systemic disease prior to surgery.

Disqualifiers

ASA classification 3 or higher (patient has severe systemic disease or worse)

Contraindication to toradol (anesthesia)

Contraindication to acetaminophen

Previous strabismus surgery

Trial design

Treatments tested in this trial

  • Tylenol

Treatment groups

80 Participants
are divided into 2 treatment groups